Specialist, Quality Assurance Operations

Duties:

This position is responsible for performing QA inspection and disposition of GMP raw materials for use in Novato Manufacturing Operations, and supports other Quality functions in the warehouse. This position reports to Manager, QA Operations Raw Materials.

The responsibilities in the role include the following:

• Perform Inspection, Review, and Disposition of incoming raw materials at the Novato GMP Warehouse(s)
• Maintain electronic status control and data entry in Oracle EBS system for GMP raw materials.

• Quality review and revision of BioMarin Raw Material Specifications and Standard Operating Procedures using the Electronic Document Management System, Veeva

• Perform visual inspection and release of primary packaging components. This includes but not limited to, managing coordination of samples, and ensuring timely maintenance and calibration of inspection equipment.

• Provide QA support to other QA raw materials activities: Control of rejected materials, deviation and change control support in TrackWise, and other Warehouse QA responsibilities, as assigned.

Skills:

• Strong communication skills-verbal and written, ability to work in a team environment
• Experience with ERP and quality management systems
• Proficient in Microsoft platforms
• Attention to detail and ability to prioritize daily tasks

Education:

Associate degree (AA/AS) or equivalent in science related area, or Biotech certificate with 2+ years of experience in a biotech environment or other regulated industry preferred.